RecruitingPHASE3INTERVENTIONAL

meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis

This study, called CANARY, wants to understand if a medicine called Empagliflozin is safe and helpful for people who have end-stage kidney disease and are using peritoneal dialysis. Even though they are on dialysis, many still have some kidney function left, which is very important for their health. This medicine, an SGLT2 inhibitor, has shown benefits for kidney disease in other groups of people, but we don't yet know if it works the same way for those on dialysis. Over two weeks, researchers will check how the medicine affects remaining kidney function and overall safety to decide if more extensive studies are needed. This information will help doctors make better decisions about treatment.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University Health Network, Toronto

Enrolment target

Start

01 Sep 2024

Estimated completion

01 Dec 2027

Peritoneal Dialysis Complication End Stage Kidney Disease Sodium-glucose Co-transporter-2 Inhibitors Kidney Dysfunction Residual Kidney Function

What is this study about?

This research study is looking into a new use for a type of medicine called an SGLT2 inhibitor, specifically one named Empagliflozin. This medicine is already used for other kidney problems and heart issues, but we don't know much about how it affects people who are on peritoneal dialysis for end-stage kidney disease. While peritoneal dialysis helps clean the blood, many people on it still have some natural kidney function left, which doctors call 'residual kidney function.' Keeping this remaining kidney function is really important for a person's health and well-being.

At the moment, there aren't many medicines that can help protect this remaining kidney function in people on dialysis. SGLT2 inhibitors have shown promise in slowing down kidney damage and protecting the heart in other patients, even those without diabetes. They seem to work by helping the kidneys in a special way that reduces pressure inside tiny kidney filters, which can protect them in the long run. The main goal of this study is to see if these protective effects also happen in people on peritoneal dialysis.

The CANARY study will be a relatively short one, lasting about two weeks. During this time, researchers will carefully check the effects of Empagliflozin on the remaining kidney function and make sure it's safe for people on peritoneal dialysis, whether they have type 2 diabetes or not. The findings from this study will be very important. If it shows the medicine is safe and works in similar ways, it could lead to larger studies and potentially offer a new treatment option for people on peritoneal dialysis, helping them keep their natural kidney function for longer. This could ultimately improve their health and quality of life.

Key takeaways

This study evaluates Empagliflozin, an SGLT2 inhibitor, for safety and effectiveness.
It targets people on peritoneal dialysis who still have some natural kidney function.
The main goal is to see if this medicine can protect remaining kidney function.
The study lasts for just two weeks.
Findings could lead to new treatment options for kidney dialysis patients.
Close medical monitoring is provided for all participants.

Who may be eligible?

To join this study, you need to be at least 18 years old and currently on peritoneal dialysis. A key requirement is that you must still have some of your own kidney function, producing at least 250 millilitres (about one cup) of urine per day, and your dialysis treatment needs to be stable and unchanged for a while. If you're taking certain blood pressure medicines (called RAAS blockers), your dose also needs to have been stable for the last month.

There are also reasons why you might not be able to join. For example, if you have Type 1 diabetes, have had a recent heart attack, stroke, or a kidney infection (peritonitis) related to your dialysis within the last month, you wouldn't be eligible. Also, if you've ever had an organ transplant, are pregnant, breastfeeding, or planning to become pregnant, or if you have certain blood disorders or active cancer, you won't be able to participate.

The research team will also check if you have any other serious health conditions or are taking other experimental drugs that might make it unsafe or difficult for you to take part. This ensures the safety of all participants and the accuracy of the study results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Are you currently on stable peritoneal dialysis?
Do you still produce at least 250ml (about a cup) of urine daily?
Have you *not* had Type 1 diabetes?
Have you *not* had a recent heart attack, stroke, or dialysis infection in the last month?
Are you *not* pregnant, breastfeeding, or planning a pregnancy during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the study medicine, Empagliflozin (25mg dose). The study will last for two weeks. During this time, you will have several appointments with the study doctors and nurses. They will ask you questions about your health, take blood and urine samples, and check your vital signs regularly to monitor how the medicine is affecting you and to ensure your safety. They will also assess your kidney function carefully. The total duration of active participation for each person is expected to be two weeks.

Potential risks and benefits

Potential benefits of taking part in this study include contributing valuable information that could lead to new treatments for people on peritoneal dialysis, potentially helping to protect remaining kidney function in the future. While individual benefits are not guaranteed, you will receive close medical monitoring during the study. Potential risks, often mild, could include side effects from the study medication, though SGLT2 inhibitors are generally well-tolerated. The medical team will discuss all known potential side effects with you before you agree to participate. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Toronto General Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is peritoneal dialysis?

Peritoneal dialysis is a type of treatment for kidney failure that uses the lining of your tummy (abdomen) to filter your blood inside your body.

What is 'residual kidney function'?

Even when you're on dialysis, your kidneys might still be working a little bit. This is called residual kidney function, and doctors believe it's very important for your health.

What is Empagliflozin and SGLT2 inhibitors?

Empagliflozin is a medicine from a group called SGLT2 inhibitors. These medicines help your kidneys remove sugar from your body and have also shown benefits for heart and kidney health.

How long will I be in the study?

If you join the study, your active participation will last for two weeks.

Will I stop my current dialysis treatment?

No, you will continue with your regular peritoneal dialysis treatment as prescribed by your doctor throughout the study.

How to find out more

Vesta Lai

vesta.lai@uhn.ca 416-340-4800 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.